Global Study Start-Up Specialist

Fortrea; North Carolina; On-site; USD 50,000 - 70,000; Full time

Job summary

Fortrea is seeking a Study Start Up Specialist with 2+ years of start-up experience to manage investigator documents and regulatory submissions across assigned countries. You will coordinate with EC/IRB, Third bodies, and Regulatory Authorities to ensure timely approvals and audit-ready documentation.

The role emphasizes accuracy, training of new hires, and collaboration with site teams in a fast-paced environment with domestic and international travel.

Qualifications

• Bachelor's degree in life sciences or equivalent; 2 years of clinical research experience.
• Strong working knowledge of ICH guidelines and RA, IRB/IEC regulations.
• Experience in site start-up, contracts and budgets negotiation.
• Ability to work in a fast-paced environment with tight timelines; travel as needed.
• Mentor and train less-experienced colleagues where suitable.

Responsibilities

• Primary contact for investigative sites during start-up and maintenance.
• Gather and submit regulatory documents (IRB/IEC, EC/IRB/Third bodies).
• Coordinate submissions with Regulatory Authorities and sponsor teams.
• Ensure documentation meets regulatory standards and timelines.
• Support site activation strategy and provide project-level timelines.

Skills

Clinical research knowledge

ICH guidelines

Regulatory submissions

Site activation coordination

Education

Bachelor's degree in life sciences

Job description

Fortrea is seeking a Study Start Up Specialist with 2+ years of start-up experience to manage investigator documents and regulatory submissions across assigned countries. You will coordinate with EC/IRB, Third bodies, and Regulatory Authorities to ensure timely approvals and audit-ready documentation.

The role emphasizes accuracy, training of new hires, and collaboration with site teams in a fast-paced environment with domestic and international travel.